Department of Health and Human Services August 31, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document is intended to describe FDA's current policies with respect to civil money penalties and no-tobacco-sale orders for retailers who violate requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to tobacco products, including the FD&C Act requirement that tobacco products may not be sold or distributed in violation of FDA's ``Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' When this guidance document is final, several provisions in the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that relate to civil money penalties and no-tobacco-sale orders will become effective.

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office of the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is contemplating the grant of worldwide co-exclusive licenses to practice the inventions embodied in the patents referred to below to Allylix, Incorporated and Valent BioSciences Corporation, having places of business in San Diego, CA and Libertyville, IL, respectively. The patent rights in these inventions have been assigned to the government of the United States of America. The patent(s) to be licensed are:

The Food and Drug Administration (FDA) has determined the regulatory review period for PRISTIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``AHRQ Grants Reporting System (GRS).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.